SAN DIEGO, Jan 14, 2013 (BUSINESS WIRE) — –Company provides 2013 financial guidance

–Conference call scheduled for 9:00 a.m. EST on January 15, 2013

Santarus, Inc. SNTS +10.99% announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS(TM) (budesonide) extended release tablets for the in patients with active, mild to moderate . The company expects to commence the commercial launch of UCERIS in March 2013.

UCERIS contains budesonide, a corticosteroid, in a novel formulation that utilizes proprietary MMX(R) multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. UCERIS was developed in collaboration with , a subsidiary of Cosmo Pharmaceuticals S.p.A.

“The FDA approval of UCERIS provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis,” said William J. Sandborn, M.D., chief, division of Gastroenterology, director, (UCSD) IBD Center and , UCSD Health System. “Specifically, UCERIS is indicated for use in the induction of remission of , an acute phase of the disease often characterized by cramping, , , bleeding, fatigue, weight loss and frequent bowel movements.”

Gerald T. Proehl, president and CEO of Santarus, said, “We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from UCERIS and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance.”

Mr. Proehl continued, “We are adding 85 new sales representatives, thereby increasing our total number of sales reps to 235, to facilitate a strong commercial launch of UCERIS. Our expanded commercial organization will promote both UCERIS and (R) (omeprazole/sodium bicarbonate) to gastroenterologists in addition to promoting our three /metabolic products to endocrinologists and other physicians.”

Financial Outlook for 2012 and 2013

Santarus Receives FDA Approval of UCERIS (Budesonide) for the Induction of
MarketWatch (press release)
Santarus, Inc. (NASDAQ:SNTS) announced today that the U.S. Food and Drug Administration (FDA) has approved UCERIS(TM) (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Santarus colitis drug approvedU-T San Diegoall 8 news articles »

About Rob Hill

In 1994, Rob was a fit, healthy 23-year-old, an amateur runner and athlete. Until that time, he had never really been sick. He didn’t even have a regular doctor. When the illness started, it progressed rapidly. Daily diarrhea. Sustained stomach cramps. The diagnosis was Crohn’s disease, an inflammatory condition of the digestive tract. It got worse, and his weight plummeted from 185 to 105 pounds. After a year and a half, it became clear that his large intestine, his colon, needed to be removed. Rob decided he had to do something about it. The Seven Summits campaign, which we call “No Guts Know Glory” grew from Rob’s love of sport, adventure and the outdoors. By taking it to the extreme, and on a global basis, Rob hopes to show people everywhere that having these diseases or having an ostomy, like Rob does, shouldn’t stop you from leading a full life. You may not be able to climb mountains, but there are so many other things you can do. To further this goal, Rob started the Intestinal Disease Education and Awareness Society (IDEAS), from his home base in Vancouver, British Columbia.

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